A Multinational, Observational Study to Investigate the Efficacy, Safety and Tolerability of Acarbose as Add-On or Monotherapy in a Range of Patients: The GlucoVIP Study

Zhang, Weiwei; Kim, Dong‐Jun; Philip, Elizabeth; Miyan, Zahid; Barykina, I. N.; Schmidt, Birgit; Stein, Herbert

doi:10.1007/s40261-013-0063-3

Cited by 38 publications

(35 citation statements)

References 41 publications

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“…is recommended. The average prescribed dose of acarbose in the NHI research database was 0.394 DDD, which is compatible with a large observational Asian study showing that 100-150 mg/day at the last visit yielded mild gastrointestinal disorders but was well tolerated (29). Gastrointestinal symptoms, such as flatulence or diarrhea, are the chief adverse effects of acarbose use, and the effects may interfere with adherence to treatment.…”

Section: Discussionsupporting

confidence: 76%

Use of an α-Glucosidase Inhibitor and the Risk of Colorectal Cancer in Patients With Diabetes: A Nationwide, Population-Based Cohort Study

et al. 2015

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OBJECTIVEAcarbose, an a-glucosidase inhibitor, has been shown to have antineoplastic effects on colorectal cancer in biomarker studies. We assessed the association between acarbose use in patients with diabetes and incident colorectal cancer. RESEARCH DESIGN AND METHODSWe conducted a nationwide, population-based study using a large cohort with diabetes in the Taiwan National Health Insurance Research Database. Patients with newly diagnosed diabetes (n = 1,343,484) were enrolled between 1998 and 2010. One control subject not using acarbose was randomly selected for each subject using acarbose after matching for age, sex, diabetes onset, and comorbidities. Cox proportional hazards regression with a competing risks analysis was used to calculate the hazard ratios (HRs) and 95% CIs for the association between acarbose use and incident colorectal cancer for each eligible case-control pair (n = 199,296). RESULTSThere were 1,332 incident cases of colorectal cancer in the cohort with diabetes during the follow-up period of 1,487,136 person-years. The overall incidence rate was 89.6 cases per 100,000 person-years. Patients treated with acarbose had a 27% reduction in the risk of colorectal cancer compared with control subjects. The adjusted HRs were 0.73 (95% CI 0.63-0.83), 0.69 (0.59-0.82), and 0.46 (0.37-0.58) for patients using >0 to <90, 90 to 364, and ‡365 cumulative defined daily doses of acarbose, respectively, compared with subjects who did not use acarbose (P for trend < 0.001). CONCLUSIONSAcarbose use reduced the risk of incident colorectal cancer in patients with diabetes in a dose-dependent manner.Colorectal cancer is one of the most common cancers worldwide (1), causing an estimated 694,000 deaths in 2012 or 9.2% of all cancer-related deaths (2). Fecal occult blood screening and improved treatment in recent decades have reduced the annual global mortality of colorectal cancer (3). The incidence of colorectal cancer varies widely by geographic region and by degree of development. Although

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Section: Discussionsupporting

confidence: 76%

Use of an α-Glucosidase Inhibitor and the Risk of Colorectal Cancer in Patients With Diabetes: A Nationwide, Population-Based Cohort Study

et al. 2015

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“…support the finding that FMC does not extensively inhibit breakdown of complex carbohydrates. Also supporting this finding is that there were no adverse gastrointestinal events often seen in pharmacological treatments for reducing blood glucose levels, such as acarbose, which inhibit these digestive enzymes [33].…”

Section: Discussionsupporting

confidence: 55%

Postprandial insulin and glucose levels are reduced in healthy subjects when a standardised breakfast meal is supplemented with a filtered sugarcane molasses concentrate

Ellis¹,

Wright²,

Clifton

et al. 2015

Eur J Nutr

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“…We acquired 5,318 reports. After title and abstract screening, 178 were potentially eligible (including 159 potentially relevant RCTs and 19 potentially relevant observational studies19202122232425262728293031323334353637). Ultimately, 14 RCTs1314151617183839404142434445 involving 2881 patients, proved eligible, and no observational studies were included.…”

Section: Resultsmentioning

confidence: 99%

Alpha-glucosidase inhibitors and hepatotoxicity in type 2 diabetes: a systematic review and meta-analysis

Zhang

Chen

et al. 2016

Sci Rep

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Alpha-glucosidase inhibitors (AGIs) was reported to be associated with several rare adverse hepatic events, but with inconsistent results. We aimed to investigate the risk of hepatotoxicity associated with the use of AGIs in patients with type 2 diabetes mellitus (T2DM), and performed a systematic review and meta-analysis. Fourteen studies (n = 2881) were eligible, all of which were RCTs. Meta-analysis of data regarding elevation of more than 3-fold the upper limit of normal (ULN) of AST and ALT showed statistically significant differences between AGIs treatment versus control (OR 6.86, 95% CI 2.50 to 18.80; OR 6.48, 95% CI 2.40 to 17.49). Subgroup analyses of elevation of more than 1.8-fold ULN of AST and ALT by dose of AGIs showed differential effects on AST and ALT (AST: OR 0.38 vs 7.31, interaction P = 0.003; ALT: OR 0.32 vs 4.55, interaction p = 0.02). Meta-analysis showed that AGIs might increase the risk of hepatotoxicity, and higher dose appeared to be associated with higher risk of hepatotoxicity. However, the evidence is limited with surrogate measures (i.e. ALT and AST), and no clinically important adverse events were observed.Alpha-glucosidase inhibitors (AGIs) are commonly used oral hypoglycemic drugs, especially in the patient population from East Asia 1-3 . The guideline of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommended the use of AGIs as a potentially first-line agent or in combination with other antihyperglycemic drugs 4 . AGIs has proven similarly efficacious as other commonly used antidiabetes agents [5][6][7] . A recent large trial 1 showed that acarbose is similar to metformin in terms of efficacy, and supports a viable choice for initial therapy in patients with newly diagnosed type 2 diabetes. Additionally, AGIs do not increase body weight, rarely cause hypoglycemia; and have minimal drug-drug interactions 1,7,8 . Meanwhile, AGIs was reported to be associated with several rare adverse hepatic events 9-11 and increase liver enzyme levels [12][13][14][15][16][17][18] . The causal relationship, however, has not been established 9 , and the magnitude of effect on the increase of liver enzyme levels remains unclear. Because these issues are often treated as adverse effects issues, and the hepatic adverse events, if any, are usually rare, individual trials are not adequate to address these important clinical questions. A meta-analysis -in which multiple studies are pooled -may offer opportunity to detect a small but clinically important difference.Thus, we carried out a systematic review of randomized controlled trials and observational studies to assess the association between hepatotoxicity and AGIs. We hypothesized that hepatotoxicity would be more frequently manifested in AGIs as opposed to no use. Figure 1 showed the study selection process. We acquired 5,318 reports. After title and abstract screening, 178 were potentially eligible (including 159 potentially relevant RCTs and 19 potentially relevant observational studies [1...

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A Multinational, Observational Study to Investigate the Efficacy, Safety and Tolerability of Acarbose as Add-On or Monotherapy in a Range of Patients: The GlucoVIP Study

Abstract: The results of this observational study support the notion that acarbose is effective, safe and well tolerated in a large cohort of Asian patients with type 2 diabetes.

Cited by 38 publications

References 41 publications

Use of an α-Glucosidase Inhibitor and the Risk of Colorectal Cancer in Patients With Diabetes: A Nationwide, Population-Based Cohort Study

Use of an α-Glucosidase Inhibitor and the Risk of Colorectal Cancer in Patients With Diabetes: A Nationwide, Population-Based Cohort Study

Postprandial insulin and glucose levels are reduced in healthy subjects when a standardised breakfast meal is supplemented with a filtered sugarcane molasses concentrate

Alpha-glucosidase inhibitors and hepatotoxicity in type 2 diabetes: a systematic review and meta-analysis

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